Study to Gather Information on the Kidney Function of Patients With Non-valvular Atrial Fibrillation (Irregularly Heart Beats Which is Not Caused by a Heart Valve Problem) Treated With Rivaroxaban or Vitamin K Antagonists

Completed

• Conditions: Non-Valvular Atrial Fibrillation
• Interventions: Drug: Rivaroxaban (Xarelto, BAY-597939); Drug: VKAs

• Registration Number: NCT04297072
• Lead Sponsor: Bayer

Brief Summary

By evaluating routine clinical practice data from the UK primary care database, researchers in this study want to gather information on the kidney function of patients with non-valvular atrial fibrillation (NVAF, irregularly heart beats which is not caused by a heart valve problem) who are treated with Rivaroxaban (non-vitamin K antagonist, brand name Xarelto) or vitamin K antagonists (VKAs). The study planned to enroll about 25,000 male or female patients who were at least 18 years old and were new users of Rivaroxaban or VKAs between 01 January 2014 and 30 September 2019. Researchers are especially interested in whether patients experienced under treatment any worsening in kidney function, the onset of acute kidney diseases or injuries. In addition, risk of worsening in kidney function in patients with or without diabetes or heart failures are of interest to the researchers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-04
• Study First Submitted QC: 2020-03-04
• Study First Posted: 2020-03-05
• Study Start: 2020-05-01
• Primary Completion: 2021-02-28
• Study Completion: 2021-02-28
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-01
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25000

Inclusion Criteria

• aged ≥18 years in the IMRD-UK database
• a first prescription for either rivaroxaban or a VKA between 01 January 2014 and 31 March 2019. The date of the first rivaroxaban/VKA prescription will be set as the start date (start of follow-up for that patient). The follow-up will be extended until 30 September 2019 to ensure that each patient has at least 6 months of potential follow-up.
• a diagnosis of AF recorded any time before start date or within 2 weeks after start date.
• registered with their general practice at least 1 year before the start date and have a recorded prescription of any drug at least 1 year before the start date.
• registered with a general practice with data considered to be up-to-standard quality.

Exclusion Criteria

• a prescription for any OAC before the start date - all first-time rivaroxaban/VKA users will therefore be OAC naïve
• a record of heart valve replacement or mitral stenosis any time before the start date or in the 2 weeks after the start date.
• a record of deep vein thrombosis, pulmonary embolism, or hip/knee surgery in the 3 months before the start date (because these are all alternative reasons for NOAC initiation).
• a record of ESRD (including renal transplant patients) on/before the start date

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rivaroxaban	Rivaroxaban (Xarelto, BAY-597939)	Participants in this group administered oral anticoagulant Rivaroxaban
Vitamin-K antagonists (VKAs)	VKAs	Participants in this group administered oral anticoagulants VKAs

Primary Outcome Measures

Name	Time	Method
A 20%, 30%, 40%, or 50% increase in serum creatinine (SCr) at any point of time during follow-up (confirmed by a subsequent measurement)	Retrospectively analysis from 01 January 2014 to 30 September 2019
Doubling of SCr from initiation (start date) at any point of time during follow-up	Retrospectively analysis from 01 January 2014 to 30 September 2019
Rate of change in eGFR from initiation (start date)	Retrospectively analysis from 01 January 2014 to 30 September 2019	To be included in the estimated glomerular filtration rates (eGFR) slope analyses at least two post-baseline assessments were required, where the first measurement was less than 120 days after index and the last was more than 180 days after the first post-baseline (reflecting sufficient time for a potential change to occur)
A 20%, 30%, 40%, or 50% decline of eGFR at any point of time during follow-up (confirmed by a subsequent measurement)	Retrospectively analysis from 01 January 2014 to 30 September 2019
Incidence of end-stage renal disease	Retrospectively analysis from 01 January 2014 to 30 September 2019
Incidence of acute kidney injury	Retrospectively analysis from 01 January 2014 to 30 September 2019

Trial Locations

Locations (1)

Many locations; 🇬🇧 Multiple Locations, United Kingdom